Sensing curved tip for surgical stapling instruments

ABSTRACT

A stapling end effector includes an anvil assembly having a distal end and defining a plurality of staple forming pockets, and a cartridge assembly pivotal relative to the anvil assembly such that the end effector is movable between open and clamped positions. The anvil assembly supports a plurality of staples corresponding to the plurality of staple forming pockets. The surgical stapling instrument further includes a sensing tip disposed on a distal end of the end effector. The sensing tip is formed of a flexible material and includes at least one sensor for measuring at least one mechanical property. The mechanical property may include force, pressure or torque.

CROSS REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No. 16/942,899, filed Jul. 30, 2020, now U.S. Pat. No. 11,266,402, the entire content of which is hereby incorporated by reference herein.

FIELD

The disclosure relates to surgical stapling instruments having curved tips, and, more particularly, the disclosure relates to surgical stapling instruments having one or more sensors in the curved tip and methods of using the surgical stapling instruments.

BACKGROUND

Surgical stapling instruments for dispensing staples to join tissue during surgical procedures are well known, as are surgical stapling instruments with a curved tip. Surgical stapling instruments including a curved tip are used for improved navigation around critical structures, and for manipulation of tissue. For example, curved tips are useful in navigating around vasculature in a thoracic space, enable passing the instrument under a vessel, and may also enable blunt dissection along tissue planes.

In thoracic surgery, such as lobectomies, clinicians are required to staple blood vessels in a specific order, namely pulmonary artery, then the pulmonary vein, and lastly the bronchus. These three (3) structures are adjacent, intertwined and/or laying one on top of the other, depending on individual anatomy. Ligation of these vessels is the most critical step of thoracic surgery. During minimally invasive surgery, the clinician does not get the haptic feedback from the end effector of the instrument. Thus, clinicians operate by sight, and have no insight what lies under the vessel, or if it is attached to another structure, and if so, how thoroughly the vessel is attached. Clinicians rely on visualization to determine how safe it is to pass the instrument between the vessels. If a vessel is perforated, torn or damaged during the passing of the surgical stapling instrument's jaws between the vessels, it is possible that the patient would bleed out within several minutes. In robotic surgery, where a clinician is at a remote console, such complications result in the clinician having to scrub in, open the chest cavity of the patient, and continue the surgery in open mode. The conversion to open mode lengthens the time of the procedure and increases the chances of complications.

Therefore, it would be beneficial to have a surgical stapling instrument with a sensing tip that would provide feedback to the clinician during a surgical procedure to avoid tearing of a vessel.

SUMMARY

A surgical stapling instrument includes a stapling end effector having a distal end and including an anvil assembly having a distal end and defining a plurality of staple forming pockets, and a cartridge assembly pivotal relative to the anvil assembly such that the end effector is movable between open and clamped positions. The anvil assembly supports a plurality of staples which are aligned with the plurality of staple forming pockets when the end effector is in the clamped position. The surgical stapling instrument further includes a sensing tip disposed on the distal end of the stapling end effector. The sensing tip is formed of a flexible material and includes at least one sensor for measuring at least one mechanical property.

In certain aspects of the disclosure, the at least one mechanical property includes force, pressure or torque. The surgical stapling instrument may further include a handle assembly and an adapter assembly extending from the handle assembly. The stapling end effector may be disposed on the adapter assembly and the adapter assembly may be operably connected to the handle assembly. The end effector may be configured to provide an indication to a clinician when the at least one mechanical property exceeds a predetermined amount. The indication may be an audible alert, a visual alert, and/or a haptic alert.

In other aspects of the disclosure, the surgical stapling instrument includes a robotic instrument having an instrument accessory and a remote control console for operating the robotic instrument. The stapling end effector may be operably connected to the instrument accessory. The remote control console may be configured to provide an indication to a clinician when the at least one mechanical property exceeds a predetermined amount. The indication may be an audible alert, a visual alert, and/or a haptic alert. The sensing tip may be formed of resilient material. The sensing tip may be formed of a polymer.

A stapling end effector includes an anvil assembly having a distal end and defining a plurality of staple forming pockets, and a cartridge assembly pivotal relative to the anvil assembly such that the end effector is movable between open and clamped positions. The anvil assembly supports a plurality of staples corresponding to the plurality of staple forming pockets. The surgical stapling instrument further includes a sensing tip disposed on a distal end of the end effector. The sensing tip is formed of a flexible material and includes at least one sensor for measuring at least one mechanical property. The mechanical property may include force, pressure or torque. The sensing tip may be formed of a resilient material. The sensing tip may be formed of a polymer. A proximal end of the end effector may be configured for operable connection with a robotic instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the disclosed surgical stapling instrument are described herein below with reference to the drawings, wherein:

FIG. 1 is a perspective view of a surgical stapling instrument according to the disclosure, including a stapling end effector having a sensing tip;

FIG. 2 is an enlarged view of the indicated area of detail shown in FIG. 1 ;

FIG. 3 is a perspective view of the stapling end effector shown in FIGS. 1 and 2 , with the sensing tip engaging tissue;

FIG. 4 is a schematic view of the stapling end effector shown in FIGS. 1-3 , during a lobectomy;

FIG. 5 is a perspective view of a robotic instrument and remote control console;

FIG. 6 is an enlarged view of the indicated area of detail shown in FIG. 5 ; and

FIG. 7 is a perspective view of the robotic instrument and remote control console shown in FIG. 5 , during a stapling procedure.

DETAILED DESCRIPTION

Surgical stapling instruments including aspects of the disclosure will now be described in detail with reference to the drawings in which like reference numerals designate identical or corresponding elements in each of the several views. In this description, the term “clinician” is used generally to refer to medical personnel including doctors, nurses, and support personnel. The term “proximal” is used generally to refer to that portion of the device that is closer to a clinician, while the term “distal” is used generally to refer to that portion of the device that is farther from the clinician.

Although aspects of the disclosure will be described as they relate to linear endoscopic and laparoscopic surgical stapling instruments, it is envisioned that the aspects of the disclosure may be incorporated into surgical instruments of various configurations, e.g., staplers for open procedures, vessel sealers, cutters, etc.

FIG. 1 illustrates a surgical stapling instrument shown generally as surgical stapler 10. The surgical stapler 10 includes a handle assembly 12, an adapter assembly 14 releasably secured to the handle assembly 12, and a loading unit 16 releasably secured to the adapter assembly 14. The handle assembly 12 and the adapter assembly 14 are configured to effect operation of the loading unit 16. The loading unit 16 may be configured for multiple uses and may include a replaceable cartridge. Although the handle assembly 12 is shown as being powered, and with a pistol grip, it is envisioned that the handle assembly 12 may be manually operated, and/or may have alternative configurations, e.g. pencil grip. In certain aspects of the disclosure, the adapter assembly 14 may be integrally formed with the handle assembly 12 and/or with the loading unit 16. For a detailed description of the structure and function of exemplary powered handle and adapter assemblies, please refer to U.S. Pat. No. 9,055,943, the entire disclosure of which is hereby incorporated by reference herein. For a detailed description of an exemplary manual handle assembly, please refer to commonly owned U.S. Pat. No. 8,070,033, the disclosure of which is hereby incorporated by reference herein.

The surgical stapler 10 also includes a display device, e.g., monitor 30, in electrical communication with the handle assembly 12. As will be described in further detail below, the monitor 30 is configured to display readings from a sensing tip 130 extending from an anvil member 120 of the stapling end effector 100 of the loading unit 16. It is envisioned that the monitor 30, may be wirelessly connected to the handle assembly 12, the loading unit 16, and/or the sensing tip 130. It is also envisioned that the monitor 30 can be integrated or supported on the handle assembly 12 or located remotely from the handle assembly 12.

FIGS. 2 and 3 illustrate the stapling end effector 100 of the loading unit 16 (FIG. 1 ). The stapling end effector 100 is pivotally secured to a body portion 18 of the loading unit 16 about a pivot member 19 (FIG. 2 ) to permit off-axis articulation of the stapling end effector 100. The stapling end effector 100 includes a cartridge assembly 110 and an anvil assembly 120 in pivotal relation with each other between an open position (FIG. 2 ) and a closed position (not shown). The cartridge assembly 110 includes a staple cartridge 112 defining a plurality of staple receiving pockets 114 supporting a plurality of staples (not shown). Either or both the cartridge assembly 110 and/or the staple cartridge 112 may be removable and replaceable by a clinician during a surgical procedure to permit reuse of the surgical stapler 10.

The anvil assembly 120 of the stapling end effector 100 of the loading unit 16 defines a plurality of staple forming pockets 122 (FIG. 4 ) for forming the plurality of staples (not shown). A sensing tip 130 extends distally from the anvil assembly 120. The sensing tip 130 is configured for dissecting, separating, or otherwise manipulating tissue. The sensing tip 130 is formed from a flexible and/or soft material, e.g., plastic, rubber or rubber-like material, or other suitable polymer, and is configured to flex and/or compress when the sensing tip 130 encounters resistance. The sensing tip 130 may be secured to the anvil assembly 120 with adhesive, friction fit, mechanical fasteners, or in any other suitable manner. In certain aspects of the disclosure, the sensing tip 130 is received over the distal end of the anvil assembly 120. Although shown disposed on the anvil assembly 120, it is envisioned that the sensing tip 130 may be supported on and extend from the cartridge assembly 110.

The sensing tip 130 of the anvil assembly 120 of the stapling end effector 100 may include various configurations depending on the surgical procedure being performed. For example, when used in endoscopic procedures, i.e., inserted through a small incision or an access port, for example, cannula 50 (FIG. 7 ), a distal-most end of the sensing tip 130 may not extend beyond an outer diameter of the stapling end effector 100 when the stapling end effector 100 is in the closed position. As such, the distal-most end of the sensing tip 130 is disposed between a plane defined by a tissue contacting surface 110 a of the cartridge assembly 110 and a plane defined by a bottom surface of the cartridge assembly 110 b to facilitate receipt through an access port. Similarly, the sides of the sensing tip 130 may also be disposed within the outer diameter of the stapling end effector 100 to facilitate receipt through an access port. For a detailed description of various tip configurations for the sensing tip 130, please refer to U.S. Pat. Nos. 8,066,166 and 9,943,311, the disclosures of which are hereby incorporated by reference herein. The tip can also be configured to be longer and extend beyond the outer surfaces of the jaws, be removable, replaceable, or bendable, or configured for use in open surgery.

The sensing tip 130 of the stapling end effector 100 of the loading unit 16 includes one or more sensors 132 a, 132 b (FIG. 2 ). The sensors 132 a, 132 b in the sensing tip 130 measure various mechanical readings such as pressure, force, and/or torque applied to the sensing tip 130. As will be described in further detail below, the sensing tip 130 may also include a global positioning system (“GPS”) tracker 132 c (FIG. 2 ). It is envisioned that one or more of the sensors 132 a, 132 b may also be configured to measure electrical properties of tissue, including, for example, tissue impedance. The sensors 132 a, 132 b may be electrically coupled to the handle assembly 12 (FIG. 1 ), or include wireless connection to the handle assembly 12, monitoring device and/or remote control console 200 (FIG. 5 ). The types of sensors used may include strain gauges, pressure transducers, temperature sensors, piezoelectric sensors. One or more of these sensors may be included in the sensing tip 130.

Various modalities may be used to alert or indicate to the clinician that the tissue being manipulated is experiencing resistance, e.g., excessive force, pressure, torque, etc., and an increased potential for damage to the tissue. The alert may be visual, e.g., digital display 32 (FIG. 1 ) on monitor 30, LEDs or other light indicators (not shown) on the handle assembly 12 (FIG. 1 ) and/or monitor 30, audibly, e.g., an alarm, and/or haptic feedback, e.g., vibration of the handle assembly 12, or in the case of remote robotic surgery, tension on the controls. It is envisioned that the amount of force, pressure, torque, etc. that triggers the alert may be adjusted by the clinician depending on the procedure being performed and the characteristics of the tissue being manipulated to avoid damage to the tissue.

FIG. 4 illustrates the stapling end effector 100 of the surgical stapler 10 (FIG. 1 ) during a surgical procedure. More particularly, the stapling end effector 100 is being used to complete lobectomy of a pulmonary lobe “PL” in which the clinician staples blood vessels in a specific order, starting with the pulmonary artery “PA”, followed by the pulmonary vein “PV”, and lastly, the bronchus “B”. Because the pulmonary artery “PA”, pulmonary vein “PV”, and the bronchus “B” may overlap and/or be intertwined, the clinician uses the sensing tip 130 of the stapling end effector 100 to navigate the end effector 100 between and around the various structures to isolate the vessels as necessary. The sensing tip 130 provides the clinician with an alert and/or feedback as the tissue is manipulated to prevent damage to the vessels.

FIG. 5 illustrates a robotic instrument 300 including an instrument accessory 310 having a stapling end effector 320 (FIG. 6 ), and a remote control console 350 for controlling the robotic instrument 300. The stapling end effector 320 is substantially similar to the stapling end effector 100 described herein above. The stapling end effector 320 includes a sensing tip 330. In addition to sensors for measuring mechanical readings, the sensing tip 330 may include a GPS tracker 132 c (FIG. 2 ) to identify the location of the end effector within a body cavity and facilitate navigation of the end effector within a patient during a stapling procedure.

FIG. 7 illustrates a surgical procedure being performed on a patient “P” using the robotic instrument 300 with the stapling end effector 320 (FIG. 6 ) secured to an instrument accessory 310. The procedure is performed through the cannula 50 received through the abdominal wall of the patient “P”. The stapling end effector 320 (FIG. 6 ) is operated by the clinician using the remote control console 350. The clinician may be able to monitor any resistance that is applied to the sensing tip 330 of the end effector during the procedure and be provided with an alert when the force, pressure, torque, etc., exceeds a predetermined amount. It is envisioned that haptic feedback may be provided through the controls throughout the stapling procedure.

Persons skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary aspects. It is envisioned that the elements and features illustrated or described in connection with one exemplary aspect of the disclosure may be combined with the elements and features of another without departing from the scope of the disclosure. As well, one skilled in the art will appreciate further features and advantages of the disclosure based on the above-described aspects. Accordingly, the disclosure is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. 

What is claimed:
 1. A surgical stapling instrument, comprising: an elongate body having a distal portion; and a stapling end effector pivotally secured to the distal portion of the elongate body, the stapling end effector having a distal end and including: a first jaw member including an anvil assembly having a distal end and defining a plurality of staple forming pockets; a second jaw member pivotal relative to the first jaw member such that the end effector is movable between open and clamped positions; and a sensing tip disposed on the distal end of the stapling end effector, the sensing tip being formed of a flexible material and including at least one sensor for measuring at least one mechanical property.
 2. The surgical stapling instrument of claim 1, wherein the at least one mechanical property includes force, pressure or torque.
 3. The surgical stapling instrument of claim 1, wherein the second jaw member includes a replaceable cartridge assembly.
 4. The surgical stapling instrument of claim 3, wherein the stapling end effector provides an indication to a clinician when the at least one mechanical property exceeds a predetermined amount.
 5. The surgical stapling instrument of claim 4, wherein the indication is an audible alert.
 6. The surgical stapling instrument of claim 4, wherein the indication is a visual alert.
 7. The surgical stapling instrument of claim 4, wherein the indication is a haptic alert.
 8. The surgical stapling instrument of claim 1, further including a handle assembly and an adapter assembly extending from the handle assembly.
 9. The surgical stapling instrument of claim 8, wherein the stapling end effector is supported on the adapter assembly and the adapter assembly is connected to the handle assembly.
 10. The surgical stapling instrument of claim 1, further including a remote control console, wherein the remote control console is configured to provide an indication to a clinician when the at least one mechanical property exceeds a predetermined amount.
 11. The surgical stapling instrument of claim 10, wherein the indication is an audible alert.
 12. The surgical stapling instrument of claim 10, wherein the indication is a visual alert.
 13. The surgical stapling instrument of claim 10, wherein the indication is a haptic alert.
 14. The surgical stapling instrument of claim 1, wherein the sensing tip is formed of resilient material.
 15. The surgical stapling instrument of claim 1, wherein the sensing tip is formed of a polymer.
 16. A surgical stapling system comprising: a surgical stapling instrument including an elongate body having a distal portion; a stapling end effector pivotally secured to the distal portion of the elongate body, the stapling end effector having a distal end and including: a first jaw member including an anvil assembly having a distal end and defining a plurality of staple forming pockets; a second jaw member pivotal relative to the first jaw member such that the end effector is movable between open and clamped positions; and a sensing tip disposed on the distal end of the stapling end effector, the sensing tip being formed of a flexible material and including at least one sensor for measuring at least one mechanical property; and a robotic instrument having an instrument accessory and a remote control console for operating the robotic instrument, wherein the stapling end effector is operably connected to the instrument accessory.
 17. A stapling end effector comprising: a first jaw member including an anvil assembly having a distal end and defining a plurality of staple forming pockets; a second jaw member pivotal relative to the first jaw member such that the end effector is movable between open and clamped positions, the second jaw assembly including a replaceable cartridge assembly; and a sensing tip disposed on a distal end of the end effector, the sensing tip being formed of a flexible material and including at least one sensor for measuring at least one mechanical property.
 18. The stapling end effector of claim 17, wherein the mechanical property includes force, pressure or torque.
 19. The stapling end effector of claim 17, wherein the sensing tip is formed of a resilient material.
 20. The stapling end effector of claim 17, wherein a proximal end of the end effector is configured for operable connection with a robotic instrument. 